Trial · NCT02524561
KEEPS Mammographic Density And Breast Health Ancillary Study
NCT02524561, Not applicable, Completed, Brigham and Women's Hospital; results first posted 2017-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. KEEPS Mammographic Density And Breast Health Ancillary Study. Trials, record NCT02524561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02524561
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KEEPS Mammographic Density And Breast Health Ancillary Study
- NCT number
- NCT02524561
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 517 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Mammographic Density, Abnormal Mammogram
- Interventions
- CEE pill, Estradiol patch, Active Progesterone, Placebo tablet, Placebo patch, Placebo progesterone
- First posted
- 2015-08-17
- Last updated
- 2017-03-08
- Results first posted
- 2017-03-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | BIRADS Breast Density | Baseline (Prior to Randomization) | Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense. |
| Primary | BIRADS Breast Density | Year 1 | Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense. |
| Primary | BIRADS Breast Density | Latest (Year 3 of 4) | Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense. |
| Secondary | Abnormal Mammogram/Biopsy | baseline to 3 years | Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | BIRADS Breast Density | Baseline (Prior to Randomization) | Women with mammograms are included. | participants | NUMBER |
| PRIMARY | BIRADS Breast Density | Year 1 | Women with mammograms 1 year after randomization | participants | NUMBER |
| PRIMARY | BIRADS Breast Density | Latest (Year 3 of 4) | Women with mammograms 3-4 years after randomization | participants | NUMBER |
| SECONDARY | Abnormal Mammogram/Biopsy | baseline to 3 years | Women with mammography reports | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| BIRADS Breast Density | CEE Pill, Active Progesterone | BIRADS 1 | 9 | participants | |
| BIRADS Breast Density | Estradiol Patch, Active Progesterone | BIRADS 1 | 9 | participants | |
| BIRADS Breast Density | Placebo | BIRADS 1 | 15 | participants | |
| BIRADS Breast Density | CEE Pill, Active Progesterone | BIRADS 2 | 42 | participants | |
| BIRADS Breast Density | Estradiol Patch, Active Progesterone | BIRADS 2 | 48 | participants | |
| BIRADS Breast Density | Placebo | BIRADS 2 | 53 | participants | |
| BIRADS Breast Density | CEE Pill, Active Progesterone | BIRADS 3 | 79 | participants | |
| BIRADS Breast Density | Estradiol Patch, Active Progesterone | BIRADS 3 | 65 | participants | |
| BIRADS Breast Density | Placebo | BIRADS 3 | 77 | participants | |
| BIRADS Breast Density | CEE Pill, Active Progesterone | BIRADS 4 | 7 | participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline: Pre-randomization Mammogram | STARTED | CEE Pill, Active Progesterone | 168 | |
| Baseline: Pre-randomization Mammogram | STARTED | Estradiol Patch, Active Progesterone | 162 | |
| Baseline: Pre-randomization Mammogram | STARTED | Placebo | 187 | |
| Baseline: Pre-randomization Mammogram | Obtained Baseline Mammogram | CEE Pill, Active Progesterone | 137 | |
| Baseline: Pre-randomization Mammogram | Obtained Baseline Mammogram | Estradiol Patch, Active Progesterone | 133 | |
| Baseline: Pre-randomization Mammogram | Obtained Baseline Mammogram | Placebo | 151 | |
| Baseline: Pre-randomization Mammogram | COMPLETED | CEE Pill, Active Progesterone | 168 | |
| Baseline: Pre-randomization Mammogram | COMPLETED | Estradiol Patch, Active Progesterone | 162 | |
| Baseline: Pre-randomization Mammogram | COMPLETED | Placebo | 187 | |
| Baseline: Pre-randomization Mammogram | NOT COMPLETED | CEE Pill, Active Progesterone | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CEE Pill, Active Progesterone | ||
| Total, all-cause mortality | Estradiol Patch, Active Progesterone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | CEE Pill, Active Progesterone | 0 | 168 |
| Total, other adverse events | Estradiol Patch, Active Progesterone | 0 | 162 |
| Total, other adverse events | Placebo | 0 | 187 |
| Total, serious adverse events | CEE Pill, Active Progesterone | 0 | 168 |
| Total, serious adverse events | Estradiol Patch, Active Progesterone | 0 | 162 |
| Total, serious adverse events | Placebo | 0 | 187 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA136918 | The effects of randomized, low-dose hormone therapy on mammographic density in KE | REXRODE, KATHRYN M; TAMIMI, RULLA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 2010 to 2014 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02524561
GET https://conductscience.org/api/trials/v1/NCT02524561/results?page=2